Status:
TERMINATED
Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Pharmacia and Upjohn
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surger...
Detailed Description
The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surger...
Eligibility Criteria
Inclusion
- Locally advanced carcinoma of the pancreas
- Arterial invasion or encasement
- Invasion/encasement of the portomesenteric veins
- Patients who have been previously denied operation
- Obstructive jaundice must be drained with a polyethylene biliary stent or surgical bypass prior to beginning treatment.
- White blood cell count \> 3500 per ml and platelet count \> 100,000 per ml
- Serum creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 1.5
- ECOG performance status \< 2
Exclusion
- Prior chemotherapy, radiotherapy, or investigational agents for pancreatic cancer
- Evidence of distant metastasis or malignant lymphadenopathy
- Concurrent malignancies
- History of allergic reactions to celecoxib or to sulfa drugs
- No non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, magnesium or aluminum containing antacids, fluconazole or lithium may be administered within 5 days of study entry, during the study and for the 30 days following the completion of all study treatments.
- Pregnant women and lactating women
- Uncontrolled or serious intercurrent illness
- HIV-positive patients receiving combination antiretroviral therapy
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00177853
Start Date
December 1 2006
End Date
July 1 2010
Last Update
July 2 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232